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Article

A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema

1
The Wellcome-Wolfson Institute for Experimental Medicine, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK
2
The Northern Ireland Clinical Trials Unit (NICTU), 1st Floor, Elliott Dynes Centre, Royal Hospitals, Belfast BT12 6BA, UK
3
Pharmacy Department, Royal Group of Hospitals, Belfast BT12 6BA, UK
4
Araim Pharmaceuticals, 580 White Plains Road, Suite 210, Tarrytown, NY 10591, USA
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(7), 2225; https://doi.org/10.3390/jcm9072225
Received: 9 June 2020 / Revised: 5 July 2020 / Accepted: 9 July 2020 / Published: 14 July 2020
(This article belongs to the Special Issue State-of-the-Art Research on Diabetic Retinopathy)
Purpose: Evaluating the effects of cibinetide in diabetic macular edema (DME). Methods: Phase 2 trial. Naïve patients with >400 µm central retinal thickness (CRT) DME in one/both eyes were recruited (May 2016–April 2017) at the Belfast Health and Social Care Trust. The study eye was that with best vision and lowest CRT. Patients self-administered cibinetide 4 mg/day subcutaneously for 12 weeks. Primary and secondary outcomes: mean change from baseline to week 12 in best corrected visual acuity (BCVA), CRT, central retinal sensitivity, tear production, patient-reported outcomes, adverse events and antibodies to cibinetide. Descriptive statistics were used; exploratory analyses focused on non-study eyes, diabetic control, serum cytokines and albuminuria. Results: Nine patients were recruited; eight completed the study. There was no improvement in mean change baseline-week 12 in BCVA (−2.9 + 5.0), CRT (10 + 94.6 microns), central retinal sensitivity (−0.53 + 1.9 dB) or tear production (−0.13 + 7.7 mm), but there was an improvement in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite scores (2.7 + 3.1). Some participants experienced improvements in CRT, tear production, diabetic control and albuminuria. No serious adverse events/reactions or anti-cibinetide antibodies were seen. Conclusions: The cibinetide 12-week course was safe. Improvements in NEI VFQ-25 scores, CRT, tear production, diabetic control and albuminuria, observed in some participants, warrant further investigation. Trial Registration: EudraCT number: 2015-001940-12. ISRCTN16962255—registration date 25.06.15. View Full-Text
Keywords: ARA 290; cibinetide; diabetes; diabetic macular edema; diabetic retinopathy; DME; erythropoietin; helix B surface peptide ARA 290; cibinetide; diabetes; diabetic macular edema; diabetic retinopathy; DME; erythropoietin; helix B surface peptide
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MDPI and ACS Style

Lois, N.; Gardner, E.; McFarland, M.; Armstrong, D.; McNally, C.; Lavery, N.J.; Campbell, C.; Kirk, R.I.; Bajorunas, D.; Dunne, A.; Cerami, A.; Brines, M. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema. J. Clin. Med. 2020, 9, 2225. https://doi.org/10.3390/jcm9072225

AMA Style

Lois N, Gardner E, McFarland M, Armstrong D, McNally C, Lavery NJ, Campbell C, Kirk RI, Bajorunas D, Dunne A, Cerami A, Brines M. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema. Journal of Clinical Medicine. 2020; 9(7):2225. https://doi.org/10.3390/jcm9072225

Chicago/Turabian Style

Lois, Noemi, Evie Gardner, Margaret McFarland, David Armstrong, Christine McNally, Nuala J. Lavery, Christina Campbell, Rita I. Kirk, Daiva Bajorunas, Ann Dunne, Anthony Cerami, and Michael Brines. 2020. "A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema" Journal of Clinical Medicine 9, no. 7: 2225. https://doi.org/10.3390/jcm9072225

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